NCT01904604

Peanut Epicutaneous Phase II Immunotherapy Clinical Trial

Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study in Children and Adults (DAIT COFAR6)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 4 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

Food allergy occurs when the immune system reacts against foods. The immune system is the part of the body that protects us from illness and germs, but it can also cause allergies. Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries. There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be severe and life threatening. The only way that you can prevent an allergic reaction is to avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and people can be accidently exposed to peanut proteins. Treatment for accidental exposure include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin) which must be carried at all times. DBV Technologies has developed an epicutaneous delivery system, a patch that puts the peanut protein on the skin.

Detailed description

This study will evaluate whether peanut epicutaneous immunotherapy can protect individuals who are allergic to peanuts from having severe allergic reactions, when accidentally exposed to peanuts. The study also looks at the safety of the treatment and the effects it has on the immune system.

Conditions

• Peanut Hypersensitivity
• Food Hypersensitivity
• Hypersensitivity
• Hypersensitivity, Immediate

Interventions

Type	Name	Description
BIOLOGICAL	Placebo Viaskin® Patch	Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.
BIOLOGICAL	Low-dose DBV712 Viaskin® Patch	100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
BIOLOGICAL	High-dose DBV712 Viaskin® Patch	250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-08-01
• Completion: 2018-08-21
• First posted: 2013-07-22
• Last updated: 2019-07-01
• Results posted: 2016-08-26

Locations

5 sites across 1 country: United States